BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENCORE MEDICAL/DJO SURGICAL COMPONENTS

    MDR report key: 1414657 · Received July 7, 2009

    Report

    Report Number
    1644408-2009-00336
    Event Type
    Other
    Date Received
    July 7, 2009
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT COMPLAINED A LOT OF GROIN PAIN. PATIENT COULD BE SENSITIVE TO METAL ION RELEASE. COMPLAINT INFORMATION IDENTIFIED DURING POST MARKET MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE MEDICAL/DJO SURGICAL COMPONENTS LARGE METAL HEAD, M-M 38MM NEU KWY ENCORE MEDICAL, L.P. 254202

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 449-38-009/263422